Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy

Unicancer

Status

Completed

Conditions

Breast Cancer

Treatments

Other: 3'-deoxy-3'-[18F]fluorothymidine

Study type

Interventional

Funder types

Other

Identifiers

NCT00534274

EU-20754

FLT01 - UC-0140/0505

2005-005166-37 (EudraCT Number)

FRE-FNCLCC-FLT-01/0505

Details and patient eligibility

About

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.

PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.

Full description

OBJECTIVES:

Primary

Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer.
Correlate PET-^18F-FLT results with histological response.

Secondary

Evaluate the correlation of early changes in tumor uptake of ^18F-FLT after the first course of chemotherapy with complete response after treatment completion.
Evaluate the correlation of early changes in tumor uptake of ^18F-FLT with histologic response in biopsies obtained after 1 course of chemotherapy.
Determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy.
Determine if initial intensity of tumor uptake of ^18F-FLT varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
Determine if the tumor uptake of ^18F-FLT during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
Evaluate the role of TK1 on the kinetics of ^18 F-FLT.
Analyze serum.
Research biomarkers of genomics, transcription, and proteomics.
Evaluate the toxicity of ^18F-FLT.

OUTLINE: This is a multicenter study.

Patients receive 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) IV and undergo positron emission tomography (PET) before the first and second courses of neoadjuvant chemotherapy. Patients receiving bisequential chemotherapy undergo ^18F-FLT-PET before the change in drugs (usually the fourth or fifth course). All patients undergo a final ^18F-FLT-PET after the last chemotherapy course but before surgery.

After completion of study therapy, patients are followed for 1 month.

Enrollment

97 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

Histologically confirmed unilateral breast cancer
- T2 or T3, any N, M0
- Unifocal by mammography and ultrasound
Negative for c-erbB2 by immunohistochemistry (IHC)
Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined
Measurable disease by ultrasound
Hormone receptor status not specified

Exclusion criteria:

Bilateral disease
Multifocal tumor
Invasive grade I lobular cancer
Metastatic disease
Stage ≥ T4 disease
Cutaneous invasion, major adherence, or inflammatory disease
Tumor overexpressing c-erbB2 by IHC (HER 2+++)
Suspected clinical or radiological lesion (examined or not)

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG performance status 0-1
Female
Menopausal status not specified
Hematologic, hepatic, and renal function normal
Not pregnant or nursing
Fertile patients must use effective contraception

Exclusion criteria:

Alcohol dependency or prior reaction to ethanol injection
Impossible to receive study therapy due to geographical, social, or psychological reasons
Prisoners or patients under supervision

PRIOR CONCURRENT THERAPY:

Inclusion criteria: